Cleared Traditional

K033868 - SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

K033868 is an FDA 510(k) clearance for SYNTHES (USA) PATIENT SPECIFIC CRANIAL/..., manufactured by Synthes (Usa). The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K033868 · Synthes (Usa) · Neurology device
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Jun 2004
Decision
192d
Days
Class 2
Risk

K033868 is an FDA 510(k) clearance for the SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 21, 2004 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K033868

510(k) Number K033868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2003
Decision Date June 21, 2004
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 55
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K033868.
PATIENT CONTOURED MESH (PCM)
K062570 · KLS-Martin L.P. · Oct 2006
STRYKER CUSTOM TI IMPLANT
K052871 · Stryker Leibinger · Dec 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc. · May 2003
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277 · Osteomed Corp. · Apr 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · Stryker Instruments · Mar 2003